Are you passionate about pharmaceutical regulatory affairs and eager to contribute to global health solutions? Apotex, a leading Canadian-based pharmaceutical company, is hiring a Regulatory Affairs Executive in Mumbai. This role focuses on product life-cycle management for Apotex products across key markets like the US, Canada, EU, Australia-New Zealand, and beyond. If you have experience in regulatory submissions and compliance, this is your chance to advance your career in the pharma industry.
Job Responsibilities
As a Regulatory Affairs Executive, you’ll play a crucial part in maintaining regulatory compliance and driving product approvals. Key duties include:
- Supporting regulatory submissions for post-approval changes and variations in US, Canada, EU, and other markets.
- Preparing and reviewing quality regulatory product life-cycle management (PLCM) submissions to ensure timely approvals.
- Maintaining regulatory databases, trackers, and documentation for compliance across global markets.
- Coordinating deficiency responses, change control assessments, and interactions with third-party manufacturers.
- Collaborating with cross-functional teams to resolve regulatory issues and ensure adherence to SOPs and guidelines.
- Communicating with external agents and suppliers for data relevant to submissions.
This position requires strong collaboration, courage, perseverance, and passion—core values at Apotex—to achieve regulatory excellence in pharmaceutical regulatory affairs.
Qualifications
To succeed in this regulatory affairs executive role, you’ll need:
- Education: A post-graduate or graduate degree in Chemistry, Pharmacy, or Life Sciences.
- Experience: Minimum 3 years in regulatory affairs, focusing on post-approval change submissions for US, Canada, EU, Australia-New Zealand, and ROW markets.
- Skills: Knowledge of regulatory guidelines, proficiency in compiling variation packages, and experience with regulatory databases and compliance programs.
Apotex values diversity and offers accommodations for applicants with disabilities during the recruitment process.
Benefits
Working at Apotex offers competitive compensation, career growth opportunities in the pharmaceutical industry, and a supportive work environment. Enjoy benefits like health insurance, professional development programs, and the chance to work on innovative medicines that improve global health access. As part of a global team, you’ll contribute to meaningful projects in regulatory affairs Mumbai.
How to Apply
Interested candidates can apply through Pharmabharat.org by submitting their resume and cover letter. Visit our job portal or contact us for more details. Applications are reviewed on a rolling basis, so apply soon to join Apotex’s regulatory affairs team.